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Efficacy and Safety of IDP-124 Lotion

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ClinicalTrials.gov Identifier: NCT03002571
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: IDP-124 Lotion Drug: IDP-124 Vehicle Lotion Phase 3

Detailed Description:
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: IDP-124 Lotion
Lotion
Drug: IDP-124 Lotion
Lotion

Active Comparator: IDP-124 Vehicle Lotion
Vehicle
Drug: IDP-124 Vehicle Lotion
Lotion
Other Name: Vehicle




Primary Outcome Measures :
  1. Primary Efficacy Variable is the IGA (Investigator's Global Assessment) score at Week 6. [ Time Frame: 6 Weeks ]
    Success is defined as achieving clear to almost clear (i.e., a score of 0 or 1) and at least a 2-grade improvement in the IGA score at the end of treatment compared with Baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Male or female at least 2 years of age and older
  • Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
  • Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable
  • Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing

Key Exclusion Criteria:

  • Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
  • Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD)
  • Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
  • History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002571


Contacts
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Contact: Lindsey Mathew 9089271400 lindsey.mathew@valeant.com

Locations
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United States, Florida
Valeant Site 01 Recruiting
Fort Lauderdale, Florida, United States, 33305
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Binu Alexander, MD Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03002571     History of Changes
Other Study ID Numbers: V01-124A-301
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases